Government Watchdog Report Reveals Conflicts of Interest and Flawed Oversight of Drug Research Approval Boards
Senator Warren requested the report from the GAO Warren: “We rely on Institutional Review Boards to make sure that drug studies and other human research is performed ethically and safely - FDA and HHS must clean up the IRB industry to keep patients safe”
Washington, D.C. – Today, United States Senators Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Bernie Sanders (I-Vt.), released a new Government Accountability Office (GAO) report revealing extensive privatization and consolidation of Institutional Review Boards (IRBs), the panels that review drug studies and other research involving human subjects to ensure they are safe and ethical. The GAO report raised concerns about conflicts of interest and oversight gaps, both exacerbated by the private equity takeover of IRBs. IRBs are overseen by the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS).
In June 2020, the lawmakers asked GAO to evaluate whether existing standards of quality, efficiency, and effectiveness provide adequate protection for participants in IRB-approved clinical trials, and to examine whether commercial IRBs have appropriate protections in place to address conflicts of interest and “pay to participate” clinical trials.
“The report’s findings – that private-equity-driven consolidation and privatization of these review boards creates panels that are ‘beholden to their clients,’ and increase the risk of harm to research subjects – are alarming.” said Senator Elizabeth Warren. “We rely on IRBs to make sure that drug studies and other human research is performed ethically and safely, and FDA and HHS should clean up the industry to keep patients safe.”
The report revealed that “the number of independent IRBs has decreased largely due to consolidation; this is, in part, related to private equity investment in IRBs.” This raises significant concerns about their effectiveness and overall ability to protect human subjects enrolled in IRB-approved trials. In particular, the report identified potential conflicts of interest in private IRB models, and identified at least one IRB that reported no policies to mitigate conflicts. GAO also revealed failures by at least four of six independent IRBs to effectively monitor approved human research projects , including finding that they have not conducted routine site visits.
“Most experts and some stakeholders described potential negative effects of private investment in IRBs,” said the report. “Three experts noted for-profit IRBs, in particular, may be more inclined to approve a protocol and do so expediently in order to satisfy a client.” And GAO also indicated that “Previous reports have suggested that unless properly managed, these conflicts put organizations at risk of placing undue pressure on the IRB to rush through reviews or approve inadequate protocols.”
The report also found several problems with oversight of IRBs by FDA and the Office for Human Research Protection (OHRP) at HHS, which are tasked with ensuring that IRBs are effectively protecting research subjects.
“These inspections are limited by inaccuracies in the data used to inform them, and the agencies have not conducted a risk-based assessment of their IRB inspection program,” said the report. “Further, while OHRP and FDA use inspections to assess whether IRBs are following regulations, the agencies have not examined the effectiveness of IRBs in protecting human subjects.”
The GAO report included four recommendations for the FDA and HHS to increase compliance with quality of care standards:
- OHRP should take steps to ensure the accuracy of protocol data collected in OHRP's IRB registry. This could include updating instructions to IRBs and examining data accuracy for a sample of IRBs.
- OHRP should conduct an annual risk assessment to determine whether the agency is conducting an adequate number of routine IRB inspections and to optimize the use of IRB inspections in the oversight of IRBs and protection of research participants.
- The FDA should conduct an annual risk assessment to determine whether the agency is conducting an adequate number of routine IRB inspections and to optimize the use of IRB inspections in the oversight of IRBs and protection of research participants.
- HHS should ensure that OHRP and FDA convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects, and implement the approaches as appropriate. These could include effectiveness measures; peer audits of IRB meetings and decisions; mock protocols; surveys of IRB members, investigators, and human research participants; or other approaches.
Senators Warren, Brown and Sanders requested this report in June 2020 to ensure that participant rights are protected and the research is conducted ethically. In November 2019, Senators Warren, Brown, and Sanders opened investigations into two of the largest for-profit IRBs, raising questions about whether they are vulnerable to conflicts of interest that could inhibit their ability to protect research subjects, and whether the two companies are maintaining appropriate ethics standards.
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